Study of Repetitive Intestinal Lavage in Patients With EHEC Associated Hemorrhagic Colitis (EHEC-PEG)

March 21, 2012 updated by: Universitätsklinikum Hamburg-Eppendorf

Repetitive Intestinal Lavage Using Polyethylene Glycol Solution in Patients With EHEC O104:H4 Infection During the German 2011 Outbreak for Prevention of Severe Thrombocytopenia With Subsequently Following Therapeutic Plasmapheresis

The investigators examined the outcome of patients with severe Enterohaemorrhagic E. Coli (EHEC) O104:H4 infection suffering from bloody diarrhoea that were at risk to develop hemolytic uremic syndrome and underwent repetitive whole bowl lavage during hospitalization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the 2011 German EHEC O104:H4 outbreak, centered in the area of Hamburg, 33 patients with EHEC associated hemorrhagic colitis were admitted to the first Department of Medicine of the Hamburg University medical centre.

The first 12 patients were treated symptomatically and received intravenous rehydration up to three liters daily.

Prompted by a good clinical response after whole bowel irrigation with polyethylene glycol-solution (PEG)in patient 13 all subsequent admitted patients (n=21) were treated with PEG-solution ( 2 liters on admission followed by one liter per day during the clinical course).

During the hospital course blood work was obtained every day and patients were examined for clinical symptoms.

Thrombocytopenia below 100.000/microliter was defined as a threshold for initiating therapeutic plasmapheresis to prevent the onset of hemolytic syndrome on an early stage.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • 1Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Proven EHEC O104:H4-infection

Presence of bloody diarrhoea + at least one of the following serological criteria:

  • platelet count below 150x10³/ μl but greater than 100x10³/ μl, serum creatine above normal level for age (> 1.1 -1.3 mg/dl), Lactate dehydrogenase (LDH) > 300 IU/l, leukocytosis ( > 12x10³/ μl ) and elevated CRP (> 5mg/l), hemoglobin < 13.8 g/dL for male patients or < 12.1 g/dL for female patients, respectively or decrease in haptoglobin

Exclusion Criteria:

  • Bloody diarrhoea due to others reasons than EHEC O104:H4 infection
  • Thrombocytopenia < 100x10³/ μl.
  • HUS, defined as platelet count below 100x10³/ μl, anaemia or decrease in haptoglobin and serum creatine above normal level for age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: SOC-treatment
Patients with EHEC associated bloody diarrhoea (n=12) receiving standard of care treatment, consisting of intravenous fluids (2-3 liters/daily), analgetics, including paracetamol and metamizol and metoclopramid, if required.
EXPERIMENTAL: PEG-Solution, daily bowel lavage
Patients with EHEC associated bloody diarrhoea (n=21)receiving SOC-treatment, consisting of i.v. fluids (2-3 liter/day), analgetics ( paracetamol and metamizol) or metoclopramid and orally administered polyethylene glycol-solution daily during the clinical course.
Drug: polyethylene glycol solution for daily bowel lavage.
At admission,patients with severe EHEC infection received two liters of orally administered electrolytes- balanced polyethylene glycol solution for bowel lavage. Treatment was continued with one liter of polyethylene glycol solution daily for repetitive intestinal lavage during the clinical course.
Other Names:
  • Klean-Prep(Norgine GmBH, Marburg, Germany).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombocytopenia (Defined as platlet count below 100.000/microliter)
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of two weeks

Following admission, blood samples were taken every day during the hospital course. When a platelet count below 100.000/microliter was measured, patients were subsequently transfered to the department of nephrology for therapeutic plasmapheresis.

As thrombocytopenia is the first abnormal laboratory finding in EHEC infected patients developing HUS, therapeutic plasmapheresis was initiated to prevent onset of mature HUS when thrombocytopenia (defined as mentioned above )was measured.
Patients will be followed for the duration of hospital stay, an expected average of two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hospitalisation
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of two weeks
Secondary outcome in this study was the duration of hospitalisation in the two groups. Duration of hospitalisation was assessed by reviewing the case notes.
Patients will be followed for the duration of hospital stay, an expected average of two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Study Director: Stefan Lüth, M.D., Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg
  • Principal Investigator: Thorben Fründt, M.D., Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (ESTIMATE)

March 22, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 22, 2012

Last Update Submitted That Met QC Criteria

March 21, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHEC-2011-PEG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemolytic Uremic Syndrome

Clinical Trials on polyethylene glycol solution for daily bowel lavage.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe